A verification study for effects of supplement with bilberry extract on the eye function and condition: effects of decreasing the eye accommodative function associated with VDT load as primary outcome -A randomized double-blind, parallel-group, placebo-controlled study
- Conditions
- Healthy Japanese adults
- Registration Number
- JPRN-UMIN000029213
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Okamoto K, Kushima M, Ishii I, Yamada T. Impacts of the Intake of a Dietary Supplement Containing Bilberry Extract on Improving Eye Functions and Conditions Caused by Visual Display Terminal Load-A Randomized, Double-blind, Parallel-group, Placebo-controlled Study-. Jpn Pharmacol Ther. 2019; 47(3): 503-515
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 44
Not provided
1.At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2.Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases 3.Subjects who were diagnosed as presbyopia or are aware of presbyopia 4.Subjects who have eye diseases, entropion or trichiasis 5.Subjects who use eye drops for treatment of eye diseases 6.Subjects who have ametropia and do not be treated orthoptics properly 7.Subjects who were treated with LASIK 8.Subjects who are strong astigmatism 9.Subjects who are experiencing eye fatigue causing by nerve function and others (except accommodative function) 10.Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", food/beverage which effective for visual function improvement, or other functional food/beverage in daily 11.Currently taking medicines (include herbal medicines) and supplements 12.Subjects who are allergic to medicines and/or the test food related products 13.Subjects who are pregnant, breast-feeding, and planning to become pregnant 14.Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 15.Subjects who are judged as ineligible to participate in the study by the principal investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Accommodative function * Assess these at screening and examination day before consuming, and at 4, 8, and 12 weeks after consuming. Perform the test before and after 60 minutes VDT load.
- Secondary Outcome Measures
Name Time Method 1. Night time visual acuity test (the recovery time of light adaptation) 2. Visual Analogue Scale (VAS) of subjective symptoms *1,2 Assess these at screening and examination day before consuming, and at 4, 8, and 12 weeks after consuming *1 Perform the test before 60 minutes VDT load. *2 Perform the test before and after 60 minutes VDT load and following a 15 minutes rest after